Trials / Completed
CompletedNCT02434107
Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node)
Controlled and Prospective Randomised Study to Compare Complete Lymph Node Dissection Versus Watchful Waiting in Patients With Malignant Melanoma With a Tumour Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 483 (actual)
- Sponsor
- University Hospital Tuebingen · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Sentinel lymph node biopsy (SLNB) is considered as standard diagnostic procedure in melanoma patients carrying a reasonable risk for metastases. In numerous studies the prognostic role of micro metastases in the sentinel node (SN) was described. However, the prognostic value of a complete lymph node dissection in patients with a positive SN is still unclear. This study was planned to analyse the survival outcome of patients with a positive SN receiving complete lymphadenectomy versus watchful waiting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Completion Lymphadenectomy | |
| PROCEDURE | Clinical Monitoring (Palpation and node ultrasound) |
Timeline
- Start date
- 2005-12-01
- Primary completion
- 2017-12-01
- Completion
- 2017-12-01
- First posted
- 2015-05-05
- Last updated
- 2022-12-21
Locations
41 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT02434107. Inclusion in this directory is not an endorsement.